Numerous plastic surgery procedures are performed each year to restore or correct the form or function of the body. Many of these procedures seek to restore a youthful appearance, or even to enhance one's existing appearance. Natural factors, such as aging and gravity, contribute to the loss of the youthful appearance. For example, skin laxity, loss of muscle tone, and attenuation of ligaments can result in ptosis (drooping) of the breast. Plastic surgeons have developed a plethora of surgical techniques to correct the ptosis of different anatomical structures that occurs with aging. These techniques vary in the type of incision, direction of incision, plane of dissection, amount of dissection, extent of repositioning of tissue, the use of different types of sutures, different suturing techniques, and different fixation techniques. Almost all of them rely on the use of the pre-existing skin envelope as the support system for the newly lifted tissue. These approaches almost invariably result in recurrent ptosis, since the surgeon is merely relying on the aging and sagging surrounding tissues that have already failed to provide the necessary support to maintain a normal appearance. At most, these techniques only slow recurrent ptosis by creating internal scars that provide limited reinforcement.
Several surgeons have attempted to reinforce their lift procedures using surgical meshes in mastopexy and breast reconstruction procedures. Some of these techniques have also incorporated the use of various reinforcing materials similar to those used in hernia repair, such as flat polymeric meshes, allografts, xenografts and autografts. For example, in 1981, Johnson described the use of MARLEX® (crystalline polypropylene) mesh to convert the support of breast tissue after mastopexy from a cutaneous origin to a skeletal origin by attaching the mesh to the area of the second rib, (Johnson, Aesth. Plast. Surg. 5:77-84 (1981)). The flat MARLEX® mesh is a permanent mesh made from polypropylene, and was implanted to provide two slings in each breast that supported the breast tissue. The MARLEX mesh was secured to the fascia with Mersilene sutures.
More recently, WO2015/006737 to Felix and WO2012/122215 to Moses have disclosed the use of resorbable meshes for mastopexy with properties that allow the meshes to resorb and be replaced with host tissue without recurrent ptosis. Furthermore these procedures can, if desired, be performed in a minimally invasive manner.
While the use of mesh in mastopexy has significant advantages for the patient, correct and precise placement of the mesh by the surgeon is required for a successful outcome. For example, the surgeon not only needs to sculpt the breast into the desired shape, but also needs to make sure that each breast is positioned at the same height. The correct positioning of the breasts can be particularly difficult because surgeons generally work with the patient lying horizontal on the operating table. As a consequence, surgeons will frequently need to make adjustments to the position of the mesh in order to make sure the breasts are correctly positioned. During this process, the surgeon will often sit the patient up on the operating table in order to identify adjustments that need to be made to the position of the mesh so that the breasts are positioned at the same height or so that the desired breast shape is obtained. Since the mesh is usually fixated to the patient's tissue using either sutures, screws, or anchors, the process of optimizing breast shape and position can be difficult because it may require, for example, sutures to be cut and placed in a different position or for screws and anchors to be removed and/or replaced. A fixation technique that would allow the surgeon to make quick adjustments to the position of the mesh during a mastopexy procedure without needing to cut and replace sutures, or remove and replace screws or bone anchors, would be very desirable. Such a technique would also be desirable in other surgical procedures, particularly where it is often necessary to make adjustments to the position of medical devices, or where fixation is difficult and requires additional time.
A fixation technique that allows a surgeon to make adjustments without removal and replacement of sutures, screws, or bone anchors would also be highly desirable in minimally invasive procedures, and in open procedures where there is restricted access to the fixation site. For example, it would be particularly desirable to have a fixation technique that allows mesh to be easily fixated in a lateral position during a mesh-assisted mastopexy procedure. In these procedures, it is often difficult for the surgeon to anchor the mesh in the lateral position because: (i) access is restricted; (ii) little tissue is available for fixation; and (iii) nerves in the lateral position, which should not be trapped, make fixation challenging. Surgeons have attempted to use barbed sutures and staples for fixation when access to a fixation site is restricted, however, these fixation systems cannot be adjusted once implanted. It would therefore be desirable to identify a method to fixate medical devices, such as mesh in a mesh-assisted mastopexy procedure, wherein the device can be more easily fixated at a restricted position and re-positioned as needed.
It is therefore an object of the invention to provide an implantable fastener for attachment of a medical device to tissue, wherein the fastener can be fixated in a first position, removed from that position, and repositioned in a second position different from the first position.
It is another object of the invention to provide an implantable fastener for attachment of a medical device to tissue, wherein the fastener can be fixed in a first position by movement in a first direction, and removed when pulled in a direction opposite to the first direction.
It is still another object of the invention to provide an implant comprising a fastener attached to a medical device, wherein the location of the fastener may be adjusted after initial implantation from a first position, and moved to a second position different from the first position by removing the fastener from the first position and implanting it at the second position.
It is yet another object of the invention to provide an implant for mastopexy, wherein the implant comprises a mesh and a repositionable fastener, and wherein the fastener can be fixated to tissue.
It is still a further object of the invention to provide implants and implantable fasteners that comprise a plurality of tissue retainers emanating from a supportive backing, wherein the tissue retainers can swivel from the plane of the supportive backing to engage tissue.